MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUR IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number	2C4041
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that debris was observed in the tubing of three (3) y-type tur/bladder irrigation sets.This was identified after opening the packaging.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: one actual device was received for evaluation; the other two samples were not received and therefore, could not be evaluated.A visual inspection was performed using the naked eye which revealed an intrinsic embedded particle related to the product or raw material.The reported condition was verified.The cause of the condition was determined to be a manufacturing related issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TUR IRRIGATION SET
• Common Device Name: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17599546
• Report Number: 1416980-2023-04206
• Device Sequence Number: 15058429
• Product Code: LJH
• UDI-Device Identifier: 00085412001067
• UDI-Public: (01)00085412001067
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K960787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 2C4041
• Device Lot Number: R23C11086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown